Hypercholesterolemia
Conditions
Brief summary
Background: It is becoming increasingly clear that individuals from all corners of the globe use probiotic dietary approaches to enhance health. More recently, probiotics have shown promise in treating a variety of disease states, due to improved strain selection, stability and delivery technologies. Objective: The purpose of this study is to determine the lipid lowering efficacy of a probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per day over 9 weeks, in subjects with hypercholesterolemia. Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 13 weeks, including a 2-week wash-out period, a 2-week run-in period and a 9 week treatment period.
Interventions
DIETARY_SUPPLEMENTCardioviva™ supplement capsule
Twice per day (BID), 9 weeks
DIETARY_SUPPLEMENTPlacebo capsule
Twice per day (BID), 9 weeks
Sponsors
Micropharma Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females, aged 20 to 75 years (bounds included) * LDL-Cholesterol above 3.4 mmol/L (\<15% variation between visits V1 and V2-1) * TG levels below 4.0 mmol/L (checked at visits V0 and V2-1) * BMI range will be 22 to 32 kg/m² * Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines) * For subjects on statin monotherapy: dosage of statin must be stable for at least 3 months prior to the study beginning (15-20% of all subjects) * Judged by the investigators as compliant (\>80%) with product consumption (check at V2-1), and motivated * Signed informed consent form prior to inclusion in the study * Note: Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study * For female subjects: effective contraceptive methods used
Exclusion criteria
* Use of cholesterol lowering prescription drugs other than statin monotherapy within the last 6 months * Use of plant sterols, omega 3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription food supplements within last 3 months * History of chronic use of alcohol (\>2 drinks/d) * Use of systemic antibodies, corticosteroids, androgens, or phenytoin * Subject having experienced any cardiovascular event (Myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months * Diabetic subject (Type I or Type II) * Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters * Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial * History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year) * Chronic user of probiotics or fibre laxative (greater than 2 doses/wk), or stimulant laxatives * History of eating disorders * Exercise greater than 15 miles/wk or 4,000 kcal/wk * For female subjects: Pregnancy, breast feeding, or intent to get pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the percent difference in LDL-cholesterol from baseline to endpoint comparing subjects receiving treatment and placebo | 9 weeks |
Countries
Czechia
Outcome results
None listed